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Revlimid (Lenalidomide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions are described in detail in other sections of the prescribing information:


  • Embryo-Fetal Toxicity [see Boxed Warnings, Warnings and Precautions (5.1, 5.2)]
  • Neutropenia and thrombocytopenia [see Boxed Warnings, Warnings and Precautions (5.3)]
  • Venous and arterial thromboembolism [see Boxed Warnings, Warnings and Precautions (5.4)]
  • Increased Mortality in Patients with CLL [see Warnings and Precautions (5.5)]
  • Second Primary Malignancies [see Warnings and Precautions (5.6)]
  • Hepatotoxicity [see Warnings and Precautions (5.7)]
  • Allergic Reactions [see Warnings and Precautions (5.8)]
  • Tumor lysis syndrome [see Warnings and Precautions (5.9)]
  • Tumor flare reactions [see Warnings and Precautions (5.10)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience in Multiple Myeloma

Data were evaluated from 703 patients in two studies who received at least one dose of REVLIMID/dexamethasone (353 patients) or placebo/dexamethasone (350 patients).

In the REVLIMID/dexamethasone treatment group, 269 patients (76%) had at least one dose interruption with or without a dose reduction of REVLIMID compared to 199 patients (57%) in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the REVLIMID/dexamethasone treatment group had at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group. Most adverse events and Grade 3/4 adverse events were more frequent in patients who received the combination of REVLIMID/dexamethasone compared to placebo/dexamethasone.

Tables 2, 3, and 4 summarize the adverse reactions reported for REVLIMID/dexamethasone and placebo/dexamethasone groups.

Table 2: Adverse Reactions Reported in ≥5% of Patients and with a ≥2% Difference in Proportion of Patients Between the REVLIMID/dexamethasone and Placebo/dexamethasone Groups
System Organ Class/ Preferred Term REVLIMID/Dex*
(n=353)
n (%)
Placebo/Dex *
(n=350)
n (%)
Blood and lymphatic system disorders
Neutropenia % 149 (42.2) 22 (6.3)
Anemia @ 111 (31.4) 83 (23.7)
Thrombocytopenia @ 76 (21.5) 37 (10.6)
Leukopenia 28 (7.9) 4 (1.1)
Lymphopenia 19 (5.4) 5 (1.4)
General disorders and administration site conditions
Fatigue 155 (43.9) 146 (41.7)
Pyrexia 97 (27.5) 82 (23.4)
Peripheral edema 93 (26.3) 74 (21.1)
Chest Pain 29 (8.2) 20 (5.7)
Lethargy 24 (6.8) 8 (2.3)
Gastrointestinal disorders
Constipation 143 (40.5) 74 (21.1)
Diarrhea@ 136 (38.5) 96 (27.4)
Nausea @ 92 (26.1) 75 (21.4)
Vomiting @ 43 (12.2) 33 (9.4)
Abdominal Pain @ 35 (9.9) 22 (6.3)
Dry Mouth 25 (7.1) 13 (3.7)
Musculoskeletal and connective tissue disorders
Muscle cramp 118 (33.4) 74 (21.1)
Back pain 91 (25.8) 65 (18.6)
Bone Pain 48 (13.6) 39 (11.1)
Pain in Limb 42 (11.9) 32 (9.1)
Nervous system disorders
Dizziness 82 (23.2) 59 (16.9)
Tremor 75 (21.2) 26 (7.4)
Dysgeusia 54 (15.3) 34 (9.7)
Hypoaesthesia 36 (10.2) 25 (7.1)
Neuropathy a 23 (6.5) 13 (3.7)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 83 (23.5) 60 (17.1)
Nasopharyngitis 62 (17.6) 31 (8.9)
Pharyngitis 48 (13.6) 33 (9.4)
Bronchitis 40 (11.3) 30 (8.6)
Infectionsb and infestations
Upper respiratory tract infection 87 (24.6) 55 (15.7)
Pneumonia @ 48 (13.6) 29 (8.3)
Urinary Tract Infection 30 (8.5) 19 (5.4)
Sinusitis 26 (7.4) 16 (4.6)
Skin and subcutaneous system disorders
Rash c 75 (21.2) 33 (9.4)
Sweating Increased 35 (9.9) 25 (7.1)
Dry Skin 33 (9.3) 14 (4.0)
Pruritus 27 (7.6) 18 (5.1)
Metabolism and nutrition disorders
Anorexia 55 (15.6) 34 (9.7)
Hypokalemia 48 (13.6) 21 (6.0)
Hypocalcemia 31 (8.8) 10 (2.9)
Appetite Decreased 24 (6.8) 14 (4.0)
Dehydration 23 (6.5) 15 (4.3)
Hypomagnesaemia 24 (6.8) 10 (2.9)
Investigations
Weight Decreased 69 (19.5) 52 (14.9)
Eye disorders
Blurred vision 61 (17.3) 40 (11.4)
Vascular disorders
Deep vein thrombosis % 33 (9.3) 15 (4.3)
Hypertension 28 (7.9) 20 (5.7)
Hypotension 25 (7.1) 15 (4.3)
Table 3: Grade 3/4 Adverse Reactions Reported in ≥2% Patients and With a ≥1% Difference in Proportion of Patients Between the REVLIMID/dexamethasone and Placebo/dexamethasone groups
System Organ Class/ Preferred Term REVLIMID/Dex#
(n=353)
n (%)
Placebo/Dex#
(n=350)
n (%)
Blood and lymphatic system disorders
Neutropenia % 118 (33.4) 12 (3.4)
Thrombocytopenia @ 43 (12.2) 22 (6.3)
Anemia @ 35 (9.9) 20 (5.7)
Leukopenia 14 (4.0) 1 (0.3)
Lymphopenia 10 (2.8) 4 (1.1)
Febrile Neutropenia % 8 (2.3) 0 (0.0)
General disorders and administration site conditions
Fatigue 23 (6.5) 17 (4.9)
Vascular disorders
Deep vein thrombosis % 29 (8.2) 12 (3.4)
Infectionsb and infestations
Pneumonia @ 30 (8.5) 19 (5.4)
Urinary Tract Infection 5 (1.4) 1 (0.3)
Metabolism and nutrition disorders
Hypokalemia 17 (4.8) 5 (1.4)
Hypocalcemia 13 (3.7) 6 (1.7)
Hypophosphatemia 9 (2.5) 0 (0.0)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism@ 14 (4.0) 3 (0.9)
Respiratory Distress @ 4 (1.1) 0 (0.0)
Musculoskeletal and connective tissue disorders
Muscle weakness 20 (5.7) 10 (2.9)
Gastrointestinal disorders
Diarrhea @ 11 (3.1) 4 (1.1)
Constipation 7 (2.0) 1 (0.3)
Nausea @ 6 (1.7) 2 (0.6)
Cardiac disorders
Atrial fibrillation @ 13 (3.7) 4 (1.1)
Tachycardia 6 (1.7) 1 (0.3)
Cardiac Failure Congestive @ 5 (1.4) 1 (0.3)
Nervous System disorders
Syncope 10 (2.8) 3 (0.9)
Dizziness 7 (2.0) 3 (0.9)
Eye Disorders
Cataract 6 (1.7) 1 (0.3)
Cataract Unilateral 5 (1.4) 0 (0.0)
Psychiatric Disorder
Depression 10 (2.8) 6 (1.7)
Table 4: Serious Adverse Reactions Reported in ≥1% Patients and With a ≥1% Difference in Proportion of Patients Between the REVLIMID/dexamethasone and Placebo/dexamethasone Groups

For all tables above:

n – Number of Patients

* - All Treatment Emergent AEs with ≥5% of Patients in REVLIMID/ Dex and at Least 2% Difference in Proportion between the Two Arms - (Safety population)

# - All Treatment Emergent Grades 3 and 4 AEs with ≥1% Patients in REVLIMID/ Dex and at Least 1% Difference in Proportion between the Two Arms - (Safety population)

& - All Treatment Emergent Serious AEs with ≥1% Patients in REVLIMID/ Dex and at Least 1% Difference in Proportion between the Two Arms - (Safety population)

@ - ADRs with Death as an outcome

% - ADRs which were considered to be life threatening (if the outcome of the event was death, it is included with death cases)

a - All PTs under the MedDRA SMQ of Neuropathy of a peripheral sensory nature will be considered listed

b - All PTs under SOC of Infections except for rare infections of Public Health interest will be considered listed

c - All PTs under HLT of Rash will be considered listed

Dex=dexamethasone

Median duration of exposure among patients treated with REVLIMID/dexamethasone was 44 weeks while median duration of exposure among patients treated with placebo/dexamethasone was 23 weeks. This should be taken into consideration when comparing frequency of adverse events between two treatment groups REVLIMID/dexamethasone vs. placebo/dexamethasone.

System Organ Class/ Preferred Term REVLIMID/Dex&
(n=353)
n (%)
Placebo/Dex&
(n=350)
n (%)
Blood and lymphatic system disorders
Febrile Neutropenia% 6 (1.7) 0 (0.0)
Vascular disorders
Deep vein thrombosis% 26 (7.4) 11 (3.1)
Infectionsb and infestations
Pneumonia @ 33 (9.3) 21 (6.0)
Respiratory, thoracic, and mediastinal disorders
Pulmonary embolism@ 13 (3.7) 3 (0.9)
Cardiac disorders
Atrial fibrillation @ 11 (3.1) 2 (0.6)
Cardiac Failure Congestive @ 5 (1.4) 0 (0.0)
Nervous system disorders
Cerebrovascular accident @ 7 (2.0) 3 (0.9)
Gastrointestinal disorders
Diarrhea @ 6 (1.7) 2 (0.6)
Musculoskeletal and connective tissue disorders
Bone Pain 4 (1.1) 0 (0.0)

Venous and Arterial Thromboembolism [see Boxed Warning, Warnings and Precautions (5.4)]

Deep vein thrombosis (DVT) was reported as a serious (7.4%) or severe (8.2%) adverse drug reaction at a higher rate in the REVLIMID/dexamethasone group compared to 3.1 % and 3.4% in the placebo/dexamethasone group, respectively. Discontinuations due to DVT adverse reactions were reported at comparable rates between groups.

Pulmonary embolism (PE) was reported as a serious adverse drug reaction including Grade 3/4 (3.7%) at a higher rate in the REVLIMID/dexamethasone group compared to 0.9% in the placebo/dexamethasone group. Discontinuations due to PE adverse reactions were reported at comparable rates between groups.

Myocardial infarction was reported as a serious (1.7%) or severe (1.7%) adverse drug reaction at a higher rate in the REVLIMID/dexamethasone group compared to 0.6 % and 0.6% respectively in the placebo/dexamethasone group. Discontinuation due to MI (including acute) adverse reactions was 0.8% in REVLIMID/dexamethasone group and none in the placebo/dexamethasone group.

Stroke (CVA) was reported as a serious (2.3%) or severe (2.0%) adverse drug reaction in the REVLIMID/dexamethasone group compared to 0.9% and 0.9% respectively in the placebo/dexamethasone group. Discontinuation due to stroke (CVA) was 1.4% in REVLIMID/ dexamethasone group and 0.3% in the placebo/dexamethasone group.

Other Adverse Reactions

In these clinical studies of REVLIMID in patients with multiple myeloma, the following adverse drug reactions (ADRs) not described above that occurred at ≥1% rate and of at least twice of the placebo percentage rate were reported:

Blood and lymphatic system disorders: pancytopenia, autoimmune hemolytic anemia

Cardiac disorders: bradycardia, myocardial infarction, angina pectoris

Endocrine disorders: hirsutism

Eye disorders: blindness, ocular hypertension

Gastrointestinal disorders: gastrointestinal hemorrhage, glossodynia

General disorders and administration site conditions: malaise

Investigations: liver function tests abnormal, alanine aminotransferase increased

Nervous system disorders: cerebral ischemia

Psychiatric disorders: mood swings, hallucination, loss of libido

Reproductive system and breast disorders: erectile dysfunction

Respiratory, thoracic and mediastinal disorders: cough, hoarseness

Skin and subcutaneous tissue disorders: exanthem, skin hyperpigmentation

Clinical Trials Experience in Myelodysplastic Syndromes

A total of 148 patients received at least 1 dose of 10 mg REVLIMID in the del 5q MDS clinical study. At least one adverse event was reported in all of the 148 patients who were treated with the 10 mg starting dose of REVLIMID. The most frequently reported adverse events were related to blood and lymphatic system disorders, skin and subcutaneous tissue disorders, gastrointestinal disorders, and general disorders and administrative site conditions.

Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events. The next most common adverse events observed were diarrhea (48.6%; 72/148), pruritus (41.9%; 62/148), rash (35.8%; 53/148) and fatigue (31.1%; 46/148). Table 5 summarizes the adverse events that were reported in ≥ 5% of the REVLIMID treated patients in the del 5q MDS clinical study. Table 6 summarizes the most frequently observed Grade 3 and Grade 4 adverse reactions regardless of relationship to treatment with REVLIMID. In the single-arm studies conducted, it is often not possible to distinguish adverse events that are drug-related and those that reflect the patient’s underlying disease.

Table 5: Summary of Adverse Events Reported in ≥5% of the REVLIMID Treated Patients in del 5q MDS Clinical Study

[a] System organ classes and preferred terms are coded using the MedDRA dictionary. System organ classes and preferred terms are listed in descending order of frequency for the Overall column. A patient with multiple occurrences of an AE is counted only once in the AE category.

System organ class/Preferred term [a] 10 mg Overall
(N=148)
Patients with at least one adverse event 148 (100.0)
Blood and Lymphatic System Disorders
Thrombocytopenia
Neutropenia
Anemia
Leukopenia
Febrile Neutropenia
91 (61.5)
87 (58.8)
17 (11.5)
12 (8.1)
8 (5.4)
Skin and Subcutaneous Tissue Disorders
Pruritus
Rash
Dry Skin
Contusion
Night Sweats
Sweating Increased
Ecchymosis
Erythema
62 (41.9)
53 (35.8)
21 (14.2)
12 (8.1)
12 (8.1)
10 (6.8)
8 (5.4)
8 (5.4)
Gastrointestinal Disorders
Diarrhea
Constipation
Nausea
Abdominal Pain
Vomiting
Abdominal Pain Upper
Dry Mouth
Loose Stools
72 (48.6)
35 (23.6)
35 (23.6)
18 (12.2)
15 (10.1)
12 (8.1)
10 (6.8)
9 (6.1)
Respiratory, Thoracic and Mediastinal Disorders
Nasopharyngitis
Cough
Dyspnea
Pharyngitis
Epistaxis
Dyspnea Exertional
Rhinitis
Bronchitis
34 (23.0)
29 (19.6)
25 (16.9)
23 (15.5)
22 (14.9)
10 (6.8)
10 (6.8)
9 (6.1)
General Disorders and Administration Site Conditions
Fatigue
Pyrexia
Edema Peripheral
Asthenia
Edema
Pain
Rigors
Chest Pain
46 (31.1)
31 (20.9)
30 (20.3)
22 (14.9)
15 (10.1)
10 (6.8)
9 (6.1)
8 (5.4)
Musculoskeletal and Connective Tissue Disorders
Arthralgia
Back Pain
Muscle Cramp
Pain in Limb
Myalgia
Peripheral Swelling
32 (21.6)
31 (20.9)
27 (18.2)
16 (10.8)
13 (8.8)
12 (8.1)
Nervous System Disorders
Dizziness
Headache
Hypoesthesia
Dysgeusia
Peripheral Neuropathy
29 (19.6)
29 (19.6)
10 (6.8)
9 (6.1)
8 (5.4)
Infections and Infestations
Upper Respiratory Tract Infection
Pneumonia
Urinary Tract Infection
Sinusitis
Cellulitis
22 (14.9)
17 (11.5)
16 (10.8)
12 (8.1)
8 (5.4)
Metabolism and Nutrition Disorders
Hypokalemia
Anorexia
Hypomagnesemia
16 (10.8)
15 (10.1)
9 (6.1)
Investigations
Alanine Aminotransferase Increased
12 (8.1)
Psychiatric Disorders
Insomnia
Depression
15 (10.1)
8 (5.4)
Renal and Urinary Disorders
Dysuria
10 (6.8)
Vascular Disorders
Hypertension
9 (6.1)
Endocrine Disorders
Acquired Hypothyroidism
10 (6.8)
Cardiac Disorders
Palpitations
8 (5.4)
Table 6: Most Frequently Observed Grade 3 and 4 Adverse Events [1] Regardless of Relationship to Study Drug Treatment

[1] Adverse events with frequency ≥1% in the 10 mg Overall group. Grade 3 and 4 are based on National Cancer Institute Common Toxicity Criteria version 2.

[2] Preferred Terms are coded using the MedDRA dictionary. A patient with multiple occurrences of an AE is counted only once in the Preferred Term category.

Preferred term [2] 10 mg
(N=148)

Patients with at least one Grade 3/4 AE
131 (88.5)
Neutropenia 79 (53.4)
Thrombocytopenia 74 (50.0)
Pneumonia 11 (7.4)
Rash 10 (6.8)
Anemia 9 (6.1)
Leukopenia 8 (5.4)
Fatigue 7 (4.7)
Dyspnea 7 (4.7)
Back Pain 7 (4.7)
Febrile Neutropenia 6 (4.1)
Nausea 6 (4.1)
Diarrhea 5 (3.4)
Pyrexia 5 (3.4)
Sepsis 4 (2.7)
Dizziness 4 (2.7)
Granulocytopenia 3 (2.0)
Chest Pain 3 (2.0)
Pulmonary Embolism 3 (2.0)
Respiratory Distress 3 (2.0)
Pruritus 3 (2.0)
Pancytopenia 3 (2.0)
Muscle Cramp 3 (2.0)
Respiratory Tract Infection 2 (1.4)
Upper Respiratory Tract Infection 2 (1.4)
Asthenia 2 (1.4)
Multi-organ Failure 2 (1.4)
Epistaxis 2 (1.4)
Hypoxia 2 (1.4)
Pleural Effusion 2 (1.4)
Pneumonitis 2 (1.4)
Pulmonary Hypertension 2 (1.4)
Vomiting 2 (1.4)
Sweating Increased 2 (1.4)
Arthralgia 2 (1.4)
Pain in Limb 2 (1.4)
Headache 2 (1.4)
Syncope 2 (1.4)

In other clinical studies of REVLIMID in MDS patients, the following serious adverse events (regardless of relationship to study drug treatment) not described in Table 5 or 6 were reported:

Blood and lymphatic system disorders: warm type hemolytic anemia, splenic infarction, bone marrow depression, coagulopathy, hemolysis, hemolytic anemia, refractory anemia

Cardiac disorders: cardiac failure congestive, atrial fibrillation, angina pectoris, cardiac arrest, cardiac failure, cardio-respiratory arrest, cardiomyopathy, myocardial infarction, myocardial ischemia, atrial fibrillation aggravated, bradycardia, cardiogenic shock, pulmonary edema, supraventricular arrhythmia, tachyarrhythmia, ventricular dysfunction

Ear and labyrinth disorders: vertigo

Endocrine disorders: Basedow’s disease

Gastrointestinal disorders: gastrointestinal hemorrhage, colitis ischemic, intestinal perforation, rectal hemorrhage, colonic polyp, diverticulitis, dysphagia, gastritis, gastroenteritis, gastroesophageal reflux disease, obstructive inguinal hernia, irritable bowel syndrome, melena, pancreatitis due to biliary obstruction, pancreatitis, perirectal abscess, small intestinal obstruction, upper gastrointestinal hemorrhage

General disorders and administration site conditions: disease progression, fall, gait abnormal, intermittent pyrexia, nodule, rigors, sudden death

Hepatobiliary disorders: hyperbilirubinemia, cholecystitis, acute cholecystitis, hepatic failure

Immune system disorders: hypersensitivity

Infections and infestations infection bacteremia, central line infection, clostridial infection, ear infection, Enterobacter sepsis, fungal infection, herpes viral infection NOS, influenza, kidney infection, Klebsiella sepsis, lobar pneumonia, localized infection, oral infection, Pseudomonas infection, septic shock, sinusitis acute, sinusitis, Staphylococcal infection, urosepsis

Injury, poisoning and procedural complications: femur fracture, transfusion reaction, cervical vertebral fracture, femoral neck fracture, fractured pelvis, hip fracture, overdose, post procedural hemorrhage, rib fracture, road traffic accident, spinal compression fracture

Investigations: blood creatinine increased, hemoglobin decreased, liver function tests abnormal, troponin I increased

Metabolism and nutrition disorders: dehydration, gout, hypernatremia, hypoglycemia

Musculoskeletal and connective tissue disorders: arthritis, arthritis aggravated, gouty arthritis, neck pain, chondrocalcinosis pyrophosphate

Neoplasms benign, malignant and unspecified: acute leukemia, acute myeloid leukemia, bronchoalveolar carcinoma, lung cancer metastatic, lymphoma, prostate cancer metastatic

Nervous system disorders: cerebrovascular accident, aphasia, cerebellar infarction, cerebral infarction, depressed level of consciousness, dysarthria, migraine, spinal cord compression, subarachnoid hemorrhage, transient ischemic attack

Psychiatric disorders: confusional state

Renal and urinary disorders: renal failure, hematuria, renal failure acute, azotemia, calculus ureteric, renal mass

Reproductive system and breast disorders: pelvic pain

Respiratory, thoracic and mediastinal disorders: bronchitis, chronic obstructive airways disease exacerbated, respiratory failure, dyspnea exacerbated, interstitial lung disease, lung infiltration, wheezing

Skin and subcutaneous tissue disorders: acute febrile neutrophilic dermatosis

Vascular system disorders: deep vein thrombosis, hypotension, aortic disorder, ischemia, thrombophlebitis superficial, thrombosis

Clinical Trials Experience in Mantle Cell Lymphoma

In the MCL trial, a total of 134 patients received at least 1 dose of REVLIMID. Their median age was 67 (range 43-83) years, 128/134 (96%) were Caucasian, 108/134 (81%) were males and 82/134 (61%) had duration of MCL for at least 3 years.

Table 7 summarizes the most frequently observed adverse reactions regardless of relationship to treatment with REVLIMID. Across the 134 patients treated in this study, median duration of treatment was 95 days (1-1002 days). Seventy-eight patients (58%) received 3 or more cycles of therapy, 53 patients (40%) received 6 or more cycles, and 26 patients (19%) received 12 or more cycles. Seventy-six patients (57%) underwent at least one dose interruption due to adverse events, and 51 patients (38%) underwent at least one dose reduction due to adverse events. Twenty-six patients (19%) discontinued treatment due to adverse events.

Table 7: Incidence of Adverse Reactions (≥10%) or Grade 3 / 4 AE (in at least 2 patients) in Mantle Cell Lymphoma

1-MCL trial AEs – All treatment emergent AEs with ≥10% of subjects

2-MCL trial Grade 3/4 AEs – All treatment-emergent Grade 3/4 AEs in 2 or more subjects

$-MCL trial Serious AEs – All treatment-emergent SAEs in 2 or more subjects

@ - AEs where at least one resulted in a fatal outcome

% - AEs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases)

#- All PTs under SOC of Infections except for rare infections of Public Health interest will be considered listed

+- All PTs under HLT of Rash will be considered listed


System Organ Class/Preferred Term
 
All AEs1 (N=134)
n (%)
Grade 3/4 AEs2 (N=134)
n (%)
General disorders and administration site conditions
Fatigue 45 (34) 9 (7)
Pyrexia$ 31 (23) 3 (2)
Edema peripheral 21 (16) 0
Asthenia$ 19 (14) 4 (3)
General physical health deterioration 3 (2) 2 (1)
Gastrointestinal disorders
Diarrhea$ 42 (31) 8 (6)
Nausea$ 40 (30) 1 (<1)
Constipation 21 (16) 1 (<1)
Vomiting$ 16 (12) 1 (<1)
Abdominal pain$ 13 (10) 5 (4)
Musculoskeletal and connective tissue disorders
Back pain 18 (13) 2 (1)
Muscle spasms 17 (13) 1 (<1)
Arthralgia 11 (8) 2 (1)
Muscular weakness$ 8 (6) 2 (1)
Respiratory, thoracic and mediastinal disorders
Cough 38 (28) 1 (<1)
Dyspnea$ 24 (18) 8 (6)
Pleural Effusion 10 (7) 2 (1)
Hypoxia 3 (2) 2 (1)
Pulmonary embolism 3 (2) 2 (1)
Respiratory distress$ 2 (1) 2 (1)
Oropharyngeal pain 13 (10) 0
Infections and infestations
Pneumonia@ $ 19 (14) 12 (9)
Upper respiratory tract infection 17 (13) 0
Cellulitis$ 3 (2) 2 (1)
Bacteremia$ 2 (1) 2 (1)
Staphylococcal sepsis$ 2 (1) 2 (1)
Urinary tract infection$ 5 (4) 2 (1)
Skin and subcutaneous tissue disorders
Rash+ 30 (22) 2 (1)
Pruritus 23 (17) 1 (<1)
Blood and lymphatic system disorders
Neutropenia 65 (49) 58 (43)
Thrombocytopenia% $ 48 (36) 37 (28)
Anemia$ 41 (31) 15 (11)
Leukopenia$ 20 (15) 9 (7)
Lymphopenia 10 (7) 5 (4)
Febrile neutropenia$ 8 (6) 8 (6)
Metabolism and nutrition disorders
Decreased appetite 19 (14) 1 (<1)
Hypokalemia 17 (13) 3 (2)
Dehydration$ 10 (7) 4 (3)
Hypocalcemia 4 (3) 2 (1)
Hyponatremia 3 (2) 3 (2)
Renal and urinary disorders
Renal failure$ 5 (4) 2 (1)
Vascular disorders
Hypotension@ $ 9 (7) 4 (3)
Deep vein thrombosis$ 5 (4) 5 (4)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare 13 (10) 0
Squamous cell carcinoma of skin$ 4 (3) 4 (3)
Investigations
Weight decreased 17 (13) 0

The following adverse events which have occurred in other indications and not described above have been reported (5-10%) in patients treated with REVLIMID monotherapy for mantle cell lymphoma.

General disorders and administration site conditions: Chills
Musculoskeletal and connective tissue disorders: Pain in extremity
Nervous system disorders: Dysguesia, headache, neuropathy peripheral
Infections and infestations: Respiratory tract infection, sinusitis, nasopharyngitis
Skin and subcutaneous tissue disorders: Dry skin, night sweats

The following serious adverse events not described above and reported in 2 or more patients treated with REVLIMID monotherapy for mantle cell lymphoma.

Respiratory, Thoracic and Mediastinal Disorders: Chronic obstructive pulmonary disease
Infections and Infestations: Clostridium difficile colitis, sepsis
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Basal cell carcinoma
Cardiac Disorder: Supraventricular tachycardia

Postmarketing Experience

The following adverse drug reactions have been identified from the worldwide post-marketing experience with REVLIMID: Allergic conditions (angioedema, SJS, TEN), tumor lysis syndrome (TLS) and tumor flare reaction (TFR), pneumonitis, hepatic failure, including fatality, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, and mixed cytolytic/cholestatic hepatitis and transient abnormal liver laboratory tests. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure [see Warnings and Precautions Section (5.5 to 5.8)].

Cases of hypothyroidism and hyperthyroidism have also been reported. Optimal control of thyroid function is recommended before start of treatment. Baseline and ongoing monitoring of thyroid function is recommended.



REPORTS OF SUSPECTED REVLIMID SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Revlimid. The information is not vetted and should not be considered as verified clinical evidence.

Possible Revlimid side effects / adverse reactions in 96 year old female

Reported by a pharmacist from Italy on 2011-10-03

Patient: 96 year old female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Revlimid



Possible Revlimid side effects / adverse reactions in 71 year old male

Reported by a physician from Thailand on 2011-10-03

Patient: 71 year old male

Reactions: Lymphoma

Adverse event resulted in: death

Suspect drug(s):
Revlimid



Possible Revlimid side effects / adverse reactions in 59 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-10-03

Patient: 59 year old male weighing 71.0 kg (156.2 pounds)

Reactions: Plasmacytoma, Pneumonia, Acute Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Dexamethasone
    Dosage: 40 milligram
    Indication: Multiple Myeloma
    Start date: 2011-07-01
    End date: 2011-07-22

Dexamethasone
    Start date: 2011-09-23

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-07-01
    End date: 2011-07-21

Dexamethasone
    Dosage: 40 milligram
    Start date: 2011-07-29
    End date: 2011-08-05

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2011-07-29
    End date: 2011-08-11

Other drugs received by patient: Avelox; Avelox



See index of all Revlimid side effect reports >>

Drug label data at the top of this Page last updated: 2014-09-23

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